ISO 13485:2003 is a standard specific to medical device quality systems that supplements the facility's existing ISO 9001:2008 standard. Some of the additional requirements relate to risk management, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are critical for the medical device industry.
“T.O. Plastics has been serving medical device customers for decades,” said Mike Vallafskey, President of T.O. Plastics. “Adding the rigorous ISO 13485:2003 Quality System strengthens our commitment to customer quality and service and positions our company for further expansion in the medical device packaging sector of the marketplace.”
“T.O. Plastics has been serving medical device customers for decades,” said Mike Vallafskey, President of T.O. Plastics. “Adding the rigorous ISO 13485:2003 Quality System strengthens our commitment to customer quality and service and positions our company for further expansion in the medical device packaging sector of the marketplace.”
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![“Another key [UDI] benefit, because we're calling that product by the same name across the healthcare supply chain… rich and robust data that we can access around supply consumption and utilization rates. One of the buzz terms we've heard during the COVID-19 crisis was what's my burn rate? How fast am I going through gowns, masks, gloves?” – Mike Schiller, Senior Director at AHRMM](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2020/08/UDI.5f4d326e41d53.png?auto=format&fit=crop&h=146&w=340)
